A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy

Exclusion Criteria

• •The patient has IgAN secondary to another condition (eg, systemic lupus erythematosus, liver cirrhosis).
• •The patient, in the opinion of the Investigator, has a rapidly progressive glomerulonephritis (rapid decline in GFR and crescents on biopsy).
• •The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (haemoglobin A1c \[HbA1c\] \>8%), or nonfasting blood glucose \>10 mmol/L (180 mg/dL) at screening.
• •The patient has undergone any organ transplantation, with the exception of corneal transplants.
• •The patient requires any of the prohibited concomitant medications (see Section 14.4).
• •The patient has been taking any systemic immunosuppressive medications for \>2 weeks within 6 months prior to screening.
• •The patient has a documented history of heart failure (New York Heart Association Class II-IV) and/or previous hospitalisation for heart failure or unexplained dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, ascites, and/or peripheral oedema.
• •The patient has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalisation for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularisation procedure) within 6 months prior to screening.
• •The patient has jaundice, hepatitis, or known hepatobiliary disease (including asymptomatic cholelithiasis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 times the upper limit of the normal range at screening.
• •The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
• •The patient has a screening haematocrit value \<27% or haemoglobin value \<90 g/L (9 g/dL).
• •The patient has a screening potassium value of \>5.5 mmol/L (5.5 mEq/L).
• •The patient has a history of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).
• •The patient has a history of serious side effects or allergic response to any AngII or ERA, including sparsentan, or has a hypersensitivity to any of the excipients in the IMP.
• •The female patient is pregnant, plans to become pregnant during the course of the trial, or is breastfeeding.
• •The patient has participated in a trial of any investigational product within 28 days prior to screening, or plans to participate in such a trial during the course of this trial.
• •The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the trial, including the ability to swallow the IMP whole.
• •The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.
• •Patients with a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity will be reviewed before consideration of the patient for enrolment.